The European Medicines Agency (EMA) was the first body to develop an overarching framework for approving biosimilars. Biosimilars have been approved for use in the European Union since 2006; they... Read more

There is no single study that will demonstrate biosimilarity. The FDA uses a “totality of the evidence” approach to review applications for biosimilar products. Manufacturers must provide data... Read more

Pharmacists are not permitted to automatically substitute a biosimilar for its reference product; they would need to contact the prescriber to approve the switch. Currently, the health care provider... Read more